K260739
- 510(k) number
- K260739
- Device name
- Profoject Pen Needles (Model A; Model B)
- Applicant
- CMT Health PTE., Ltd. SG
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2026-07-15
- Date received
- 2026-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260739.pdf
Official FDA record: K260739
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.